VR vs. Conventional Cycling Exercise for Geriatric Inpatient Physical Activation

Sponsor

Bispebjerg Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05123638

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

15.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to investigate whether virtual reality assisted stationary cycling exercise results in more physical activity than conventional unsupervised stationary cycling exercise. Physical activity levels are reported for both exercise duration and volume and non-exercise activity.

Condition or Disease	Intervention/Treatment	Phase
Inactivity, Physical Treatment Adherence and Compliance Hospital Acquired Condition Sarcopenia	Device: Virtual reality cycling exercise Behavioral: Unsupervised stationary cycling exercise	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Stratified randomization (based os Cumulated-Ambulation Score of 6 vs. <6) of geriatric inpatients to either VR assisted stationary cycling exercise or conventional stationary cycling exercise.Stratified randomization (based os Cumulated-Ambulation Score of 6 vs. <6) of geriatric inpatients to either VR assisted stationary cycling exercise or conventional stationary cycling exercise.

Masking:

None (Open Label)

Masking Description:

Since there is only a single investigator conducting this study and due to the nature of exercise intervention, it is impossible to facilitate masking terms in this trial.

Primary Purpose:

Other

Official Title:

Is Virtual Reality Assisted Cycling Exercise Superior to Conventional Stationary Cycling in Geriatric Patients for Increasing Physical Activity Levels During Hospitalization?

Anticipated Study Start Date :

Nov 8, 2021

Anticipated Primary Completion Date :

Dec 22, 2021

Anticipated Study Completion Date :

Jan 7, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Virtual reality cycling exercise These patient participants will receive 1 session of unsupervised stationary cycling exercise with the SYNCSENSE VR-technology every weekday of participation and be allowed up to 30min of voluntary exercise pr. session.	Device: Virtual reality cycling exercise Daily voluntary cycling for up to 30 minutes with the virtual reality technology
Active Comparator: Conventional cycling exercise These patient participants will receive 1 session of unsupervised stationary cycling exercise on every weekday of participation and be allowed up to 30min of voluntary exercise pr. session.	Behavioral: Unsupervised stationary cycling exercise Daily voluntary cycling for up to 30 minutes (WITHOUT the virtual reality technology)

Arm

Intervention/Treatment

Experimental: Virtual reality cycling exercise

These patient participants will receive 1 session of unsupervised stationary cycling exercise with the SYNCSENSE VR-technology every weekday of participation and be allowed up to 30min of voluntary exercise pr. session.

Device: Virtual reality cycling exercise

Daily voluntary cycling for up to 30 minutes with the virtual reality technology

Active Comparator: Conventional cycling exercise

These patient participants will receive 1 session of unsupervised stationary cycling exercise on every weekday of participation and be allowed up to 30min of voluntary exercise pr. session.

Behavioral: Unsupervised stationary cycling exercise

Daily voluntary cycling for up to 30 minutes (WITHOUT the virtual reality technology)

Outcome Measures

Primary Outcome Measures

Voluntary exercise duration [3-14 days]
How long the patients choose to exercise with vs. with out VR assistance measured on the stationary bikes internal timer

Secondary Outcome Measures

Voluntary exercise amount [3-14 days]
How much voluntary cycling work does the participants choose to put out during session calculated from the bikes internal counter and external equations
Measures of 24 hour physical activity and sedentary behavior [3-14 days]
Measured with 24 hour thigh mounted movement sensor

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Admitted to geriatric ward at Bispebjerg Hospital with an minimum of 3 days (anticipated) left of stay.
Volunteering

Exclusion Criteria:

Unable to be easily mobilized by training staff.
Unable to perform the stationary cycling exercise modality.
Lack of Danish speaking and reading skills.
Lack of senses (blind, deff pr heavily hearing impaired).
Suffering from delirium, vertigo or dementia beyond a moderate degree.
Judged medically contraindicated by therapeutic, medical or care staff

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bispebjerg Geriatric Ward	Bispebjerg		Denmark	2400

Sponsors and Collaborators

Bispebjerg Hospital

Investigators

Study Director: Charlotte Suetta, CopenAge

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Charlotte Suetta, Clinical professor, Bispebjerg Hospital

ClinicalTrials.gov Identifier:

NCT05123638

Other Study ID Numbers:

VR+Cycling

First Posted:

Nov 17, 2021

Last Update Posted:

Nov 17, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Charlotte Suetta, Clinical professor, Bispebjerg Hospital

Virtual Reality

Patient Preference

Additional relevant MeSH terms:

Sarcopenia

Iatrogenic Disease

Study Results

No Results Posted as of Nov 17, 2021